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Manufacture Advanced Medicine

This Week’s CGT News: Sarepta Gets FDA Platform Technology Designation

| 4 min read

Our latest news roundup reports on dysfunction observed in edited blood stem cells, and RFK Jr’s support for experimental treatments.

Manufacture Advanced Medicine

Using Machine Learning to Improve Gene Therapy Design

| Stephanie Vine | 2 min read

Stanford University researchers explore how zinc fingers can enhance gene therapy.

Manufacture Bioprocessing - Upstream & Downstream

Advances and Opportunities in Biologics Formulation

| Heonchang Lim, Derrick Katayama | 2 min read

The challenges of developing optimized biologics formulations are well known, but the good news is that the industry continues to develop solutions.

Manufacture Facilities

Worst-Case Scenarios and Ideal Facilities in Fill-Finish

| Stephanie Vine | 7 min read

Is the complexity of the fill-finish process under appreciated in pharma manufacturing? Four experts discuss why it’s important to get it right.

Manufacture Advanced Medicine

This Week’s CGT News: Smart Cell Therapy Facility for Japan

| 5 min read

Our latest news roundup reports on a cell therapy facility expansion in Princeton, a magnet to capture T cells, and more.

Manufacture Advanced Medicine

Gene Therapies for Newborns

| Stephanie Vine | 2 min read

Work from the lab of Luigi Naldini identifies postnatal window for in vivo gene editing, without the need for conditioning or transplantation

Manufacture Vaccines

Can Preconditioning Strategies Improve Cancer Vaccine Efficacy?

| Stephanie Vine | 2 min read

Researchers explore how different preconditioning approaches can impact the performance of dendritic cell vaccines for cancer.

Manufacture Advanced Medicine

Clinical Hold for Rocket Pharmaceuticals’ Gene Therapy

| Stephanie Vine | 2 min read

Patient fatality reported in clinical trial for investigational gene therapy for Danon disease.

Manufacture Facilities

Fill-Finish: The Easy Step? Think Again

| Stephanie Vine | 10 min read

Mistakes in fill-finish can lead to lost batches, lost profits, and increased regulatory scrutiny. Four experts discuss.

Manufacture Advanced Medicine

This Week’s CGT News: The Next Generation of AAVs

| 5 min read

Our latest news roundup reports on a gene therapy for Duchenne muscular dystrophy that can be re-dosed, a free toolkit for gene delivery, and more.


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May Issue of The Medicine Maker